Anaplastic AstrocytomaPhase 3NCT01656980
Safety and Efficacy Study of Intracranially Implanted Carmustine to Treat Newly Diagnosed Malignant Glioma
A Phase 3 study testing Carmustine and tumor resection surgery in people with Anaplastic Astrocytoma and Anaplastic Oligodendroglioma, run by Shandong Lanjin Pharmaceuticals Co.,Ltd at 1 site in China.
Trial summary
The purpose of the study is to determine the safety and efficacy of intracranially implanted Carmustine in the treatment of patients with primary malignant glioma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Anaplastic Oligoastrocytoma
- What is being tested?
- Carmustine and tumor resection surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 236 participants
- Where
- 1 siteChina
- Study dates
- Aug 2012to Dec 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmation of high grade glioma(WHO III or above)by frozen or squash preparation;
- Patients must be 18 to 70 years old, signed ICF;
- At least 4 weeks after previous chemotherapy (6 weeks since nitrosoureas);
- KPS ≥ 60;
- Unilateral, Supratentorial, solitary lesion and not crossing the midline
- No obvious important organ dysfunction: Hepatic function:Serum total bilirubin ≤1.5 times upper limit of laboratory normal; Aspartate aminotransferase (AST) and/or Alanine aminotransferase (ALT)<2.5 times upper limit of laboratory normal; Renal function:Serum creatinine ≤1.5 times upper limit of laboratory normal;
- Not Pregnant or lactating for women of childbearing potential.
Who cannot join
- Underwent cytoreductive surgery(excluded stereotactic biopsy);
- With chemotherapy or brain radiotherapy history;
- Tumor located at ventricular system, Open ventricle tumor cavity postoperatively;
- Concomitant with other life-threatening diseases and with life expectancy <12 months;
- Allergic to nitrosourea drugs;
- With history of intracranial radiotherapy or implant chemotherapy;
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- With serious cardiac, pulmonary, hepatic and renal dysfunction, poor glycemic control;
- Experienced > 3 times of Large epilepsy within one month preoperatively.
- Investigators thought unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tiantan Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 100050
Yan H Sun, M.D., +86-1360-1389-945, sunyanhui1109@yahoo.com.cn
Jian J Yu, Master, +86-15336402751, Yujj@lanjin.cn
About this study
Official title: Phase 3 Study of Carmustine Sustained Release Implant (CASANT) to Treat Newly Diagnosed Malignant Glioma
The purpose of the study is to determine the safety and efficacy of intracranially implanted Carmustine in the treatment of patients with primary malignant glioma.
Read the detailed description
Malignant gliomas recur mostly 2 cm within originated area. Local therapies therefore become particular important. Gliadel wafer developed in the States and marketed in the developed countries is an example of such treatments. The product in this study, Carmustine Sustained Release Implant (CASANT), is similar to that of Gliadel wafer as for the API(Active Pharmaceutical Ingredient), but different as for drug delivering system. As required, the preliminary clinical studies were conducted in China. Based on the results of phase I/II , 8-10 wafers containing given dose of BCNU will be administered intracranially in this phase III to the tumor resected cavity to investigate the safety and efficacy in the treatment of primary malignant glioma in 236 patients.
- Conditions
- Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Anaplastic Oligoastrocytoma, Glioblastoma
- Being tested
- Carmustine, tumor resection surgery
- Medical subject headings
- Astrocytoma, Oligodendroglioma, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarmustineDrug
Also called Trade name: CASANT, Other name: BCNU
As Experimental group, subjects will accept specified wafers of carmustine in the cavity while gliomas maximally be resected.
tumor resection surgeryProcedure or surgery
Also called blank control group
For this group, subjects will accept routine tumor resection surgery and place no implant wafers.
| Study group | Role | What they receive |
|---|---|---|
| Carmustine Sustained Release Implant | Experimental | For subjects in this group, they will accept intracranially implanted carmustine intraoperatively. Receives: Drug: Carmustine |
| Tumor Resection Surgery | Sham comparator | For subjects in this control group, they accept no implants while gliomas maximally be resected. Receives: Procedure: tumor resection surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: 15 months
Secondary outcomes (5)
Progress Free Survival
Measured: 15 months
Overall Survival Rate at 12 months
Measured: 15 months
Karnofsky Performance Status(KPS)
Measured: 15 months
Quality of Life(QOL)
Measured: 15 months
Safety of intracranially implanted carmustine after maximal tumor resection
Occurrence rate of adverse event and serious adverse event revealed by laboratory test outcomes including blood routine and chemistry as well as physical examination, vital signs including blood pressure, temperature, respiratory rate , heart rate.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anaplastic AstrocytomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Lanjin Pharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yan H Sun, M.D., Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01656980
- Sponsor's protocol ID
- LJ-Glioma 3. 3.0 Version
- Status last verified
- Aug 2012
- First submitted
- 1 Aug 2012
- Last updated
- 3 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of Carmustine Sustained Release Implant (CASANT) to Treat Newly Diagnosed Malignant Glioma
- ClinicalTrials.gov ID
- NCT01656980
- Acronym / sponsor ID
- LJ-Glioma 3. 3.0 Version
- Conditions
- Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Anaplastic Oligoastrocytoma, Glioblastoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Shandong Lanjin Pharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 3 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine the safety and efficacy of intracranially implanted Carmustine in the treatment of patients with primary malignant glioma.
Detailed description
Malignant gliomas recur mostly 2 cm within originated area. Local therapies therefore become particular important. Gliadel wafer developed in the States and marketed in the developed countries is an example of such treatments. The product in this study, Carmustine Sustained Release Implant (CASANT), is similar to that of Gliadel wafer as for the API(Active Pharmaceutical Ingredient), but different as for drug delivering system. As required, the preliminary clinical studies were conducted in China. Based on the results of phase I/II , 8-10 wafers containing given dose of BCNU will be administered intracranially in this phase III to the tumor resected cavity to investigate the safety and efficacy in the treatment of primary malignant glioma in 236 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carmustine Sustained Release Implant | Experimental | Drug: CarmustineFor subjects in this group, they will accept intracranially implanted carmustine intraoperatively. |
| Tumor Resection Surgery | Sham comparator | Procedure: tumor resection surgeryFor subjects in this control group, they accept no implants while gliomas maximally be resected. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Confirmation of high grade glioma(WHO III or above)by frozen or squash preparation;
- Patients must be 18 to 70 years old, signed ICF;
- At least 4 weeks after previous chemotherapy (6 weeks since nitrosoureas);
- KPS ≥ 60;
- Unilateral, Supratentorial, solitary lesion and not crossing the midline
Key exclusion criteria (9 listed)
- Underwent cytoreductive surgery(excluded stereotactic biopsy);
- With chemotherapy or brain radiotherapy history;
- Tumor located at ventricular system, Open ventricle tumor cavity postoperatively;
- Concomitant with other life-threatening diseases and with life expectancy <12 months;
- Allergic to nitrosourea drugs;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarmustineAlso: Trade name: CASANT, Other name: BCNUAs Experimental group, subjects will accept specified wafers of carmustine in the cavity while gliomas maximally be resected. | Drug | Carmustine Sustained Release Implant |
| tumor resection surgeryAlso: blank control groupFor this group, subjects will accept routine tumor resection surgery and place no implant wafers. | Procedure or surgery | Tumor Resection Surgery |
Primary outcome
Overall Survival
Time frame: 15 months
5 secondary outcomes
Progress Free Survival
Time frame: 15 months
Overall Survival Rate at 12 months
Time frame: 15 months
Karnofsky Performance Status(KPS)
Time frame: 15 months
Quality of Life(QOL)
Time frame: 15 months
Safety of intracranially implanted carmustine after maximal tumor resection
Time frame: 15 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2012.
- You will see subjects recruitment information when visiting above website.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yan H Sun, M.D. principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Carmustine and tumor resection surgery in people with Anaplastic Astrocytoma and Anaplastic Oligodendroglioma, run by Shandong Lanjin Pharmaceuticals Co.,Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan H Sun, M.D. (+86-1360-1389-945, sunyanhui1109@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2012.